QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.

On 7^th November 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs with the addition of one new substance. The current list of SVHCs now contains 242 substances.

The IVDR transition period has been extended, allowing importers to continue selling products certified under the previous IVDD directive. This extension provides more time to comply with labeling, documentation, and certification requirements, minimizing non-compliance risks and maintaining market access.

The European Commission has released a Q&A document regarding the extension of the IVDR transition period, as well as an updated Q&A document on the extension of the MDR transition period, pursuant to Regulation 2024/1860, which was recently published.

In 2017, the FDA initiated MRAs with EU and UK, for human drugs. On May 30th, the FDA once again signed an MRA, with 16 EU countries, this time concerning veterinary drugs.

EU AI Act is to be the world's first AI law. European Parliament passed the draft on June 14. However, it faced opposition from industry organizations like MedTech Europe, the Confederation of European Business, and Team-NB (European Association for Medical Devices Notified Bodies).

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By the end of 2024, all electronic devices sold in the EU will have to be equipped with a USB Type-C charging port. While the impact of the new regulations on the home health product industry remains to be seen, it is clear that compliance with the universal charging port requirements will be necessary for manufacturers operating within the EU.